Kornimate/medical-research-clean huggingface dataset:
coxsackie virus in pregnancy and congenital heart disease

Conditions: Congenital Heart Disease in Pregnancy

Summary: investigators would like to find out if a woman's exposure to coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(chd)

the investigator proposes that coxsackievirus group b (cvb) infection in early pregnancy induces pathological changes in congenital heart defects. to test the hypothesis, it will be determined if the incidence of cvb infection in women with babies that are congenital heart defect-(chd) affected pregnancies are higher than in control subjects. after informed consent participants will provide the following samples during one study visit: 10 ml (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire our 3 study groups are the following-group 1 is hypoplastic left heart syndrome or hlhs effected pregnancies. group 2 is ochd- other congenital heart defects and group 3 is unaffected controls (uc) also known as healthy controls. after informed consent participants will provide the following samples: 10 ml (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab). a health history review and questionnaire will also be obtained. analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus. note- prior to april 2016- the protocol and the healthy control (hc)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. blood, nose and stool samples were obtained at all three visits.

Eligibility criteria:
inclusion criteria * fetal echocardiogram demonstrating one of the following: hypoplastic left heart syndrome (hlhs) or variant, other congenital heart disease (ochd), or unaffected control (uc) * gestation is ≥20 wks-fetal group (hlhs, ochd) * subject is able and willing to give informed consent. exclusion criteria * subject is \< 18 years of age. * subject is pregnant with twins or multiple gestations. * subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect). * subject's pregnancy is affected by chromosomal anomalies (ochd \& uc groups) * maternal history of chromosomal anomaly (ochd \& uc groups) * infertility treatment for current/index pregnancy
pd-l1 expression in cancer (pecan study).

Conditions: Non-small Cell Lung Cancer; Melanoma

Summary: measurement of pd-l1 expression in cancer to monitor treatment response. a prospective non-blinded, single centre, single interventional arm diagnostic imaging study. to determine the baseline level and variability within and between patients and tumour types of pd-l1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using \[99mtc\]-anti-pd-l1 spect/ct and immunohistochemistry.

using \[99mtc\]-labeled anti-pd-l1 single-domain antibody, this study aims to prospectively measure changes in pd-l1 expression determined with spect/ct imaging and correlate these changes with response to anti-pd(l)1 immunotherapy.

Eligibility criteria:
inclusion criteria: * aged 18 or above * patients with histologically confirmed nsclc or melanoma scheduled for pd1/pdl1 immunotherapy alone or in combination with other systemic anti-cancer therapy. * willingness and ability to comply with scheduled study visits and tests. exclusion criteria: * pregnant or lactating women * concomitant uncontrolled medical conditions * patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days * more than 3 months between ihc pdl1 and study recruitment * patients who have received other systemic anti-cancer therapy within preceding 14 days * prognosis less than 3 months * previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients

Keywords: immunotherapy checkpoint inhibitors molecular imaging non-small cell lung cancer melanoma
neo-adjuvant gemcitabine, epirubicin, abi-007 (gea) in locally advanced or inflammatory breast cancer

Conditions: Breast Cancer

Summary: in this trial we will evaluate abi-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen: induction neo-adjuvant: epirubicin + gemcitabine + abi-007 + pegfilgrastim postoperative adjuvant: gemcitabine + abi-007 + pegfilgrastim upon completion of chemotherapy, all er and/or pr+ patients will receive tamoxifen or an aromatase inhibitor at physician discretion.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * locally advanced/inflammatory adenocarcinoma of the breast * 18 years of age or older * normal heart function * able to perform activities of daily living with minimal assistance * no prior chemotherapy for breast cancer * adequate bone marrow, liver and kidney function * no evidence or history of significant cardiovascular abnormalities * sentinel node or axillary dissection * sign an informed consent form exclusion criteria: you cannot participate in this study if any of the following apply to you: * pregnant or breast feeding * history of heart disease with congestive heart failure * heart attack within the previous 6 months * prior chemotherapy or hormone therapy for breast cancer * history of active uncontrolled infection please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: locally advanced breast cancer inflammatory breast cancer breast cancer abraxane nab paclitaxel epirubicin gemcitabine gemzar
efficacy and safety of valsartan plus hydrochlorothiazide in patients with slight hypertension and target organ damage

Conditions: Hypertension; Ventricular Remodeling; Erectile Dysfunctions

Summary: patients with slight increase in blood pressure levels have an increased cardiovascular risk. in particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. on the other hand, the last american and european guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. in agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. on this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage. the aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function


Eligibility criteria:
inclusion criteria: * aged 18-65 * gender males * high-normal blood pressure (130-139 mmhg or 85-89 mmhg) * first degree hypertension (140-159 mmhg or 90-99 mmhg) * cardiac remodeling (left ventricular concentric hypertrophy exclusion criteria: * coronary artery disease * secondary hypertension * diabetes mellitus * incapacity to perform ergometry test * anemia (hb \< 12.5g/dl) * cardiac valve disease * arrhythmia
heel cushion for plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the investigators study aim to evaluate the efficacy of psu heel cushion in treatment of plantar fasciitis. the investigators will do a randomized controlled trial in patient with plantar fasciitis compared with stretching exercise alone. the outcome measurement include heel pain improvement, compliance, satisfaction, foot functional score at 6 months.


Eligibility criteria:
inclusion criteria: * patient with plantar fasciitis exclusion criteria: * rheumatologic problem such as rheumatoid arthritis * latex allergy * pregnancy * previous surgery around foot and ankle

Keywords: plantar fasciitis heel cushion treatment
efficacy and safety of adjuvant metformin for operable breast cancer patients

Conditions: Breast Cancer

Summary: the investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (dm) may improve their body condition including weight loss. in this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-dm.


Eligibility criteria:
inclusion criteria: * operable breast cancer patients with bmi ≥ 23 or 100 ≤ fbs \< 126 * from 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy * no drug use except tamoxifen * normal otpt \& serum creatinine (\<=uln) * ecog performance status 0-2 or karnofsky ps 60-100% * life expectancy \> 12 * absolute neutrophil count ≥ 1.5 x 10\^9/l * platelets ≥ 100 x 10\^9/l * pregnancy(-) \& without plan for pregnancy * sign a written informed consent form exclusion criteria: * type i or ii dm or concurrent use of dm control agents * prior use of metformin * hypoglycemia (fbs\< 70 with clinical symptom) * concurrent investigational or commercial agents * other diet or drug intervention for weight loss * concurrent use of steroid * abnormal liver and/or renal function * symptomatic congestive heart failure / cardiac arrhythmia / angina pectoris * ongoing or active infection * lactic acidosis * pregnancy or ongoing breast feeding * anorexia, bulimia, nausea due to other disease for longer than 1 month * allergies or allergic reactions attributed to oral medications * inability to swallow or digest oral medications * physical or psychiatric illness that would limit compliance with study protocol * participants in other clinical trial
muscle atrophy in sepsis

Conditions: Atrophy; Sepsis; Weakness

Summary: severe sepsis will provoke signals leading to muscle atrophy and weakness. electrical stimulation will reduce the impact of sepsis.

hypothesis 1: severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle. hypothesis 2: electrical stimulation will improve muscle strength in patients with sepsis. hypothesis 3: electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis. hypothesis 4: the ratio of catabolic:anabolic gene expression on day 3 will be positively correlated with the severity of clinical weakness on day 7

Eligibility criteria:
inclusion criteria: * severe sepsis for \< 72hr

Keywords: sepsis atrophy muscle weakness
a phase i dose escalation combination study in patients with chronic myelogenous leukemia (cml) and philadelphia chromosome-positive (ph+) acute lymphoblastic leukemia (all)(0457-009)(terminated)

Conditions: Chronic Myelogenous Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Summary: this study will evaluate mk0457 in combination with dasatinib in patients with chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. efficacy and safety will be evaluated.


Eligibility criteria:
inclusion criteria: * patients must have chronic myelogenous leukemia (cml) or philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ all) * patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for cml or ph+ all and be evaluable for hematologic response prior to entering the study * patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry * patients with active cns disease are included and may be treated concurrently with intrathecal therapy as per institutional standards exclusion criteria: * patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility * patient has unresolved more than or equal to grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry * patient has known hypersensitivity to the components of study drug or its analogs * patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study * patient has symptomatic ascites, pericardial or pleural effusion. a patient who is clinically stable following treatment for these conditions is eligible * patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy * patient has a lvef \<40% by multigated radionucleotide angiography (muga) or echocardiography
corticosteroid and lidocain injections for tennis elbow

Conditions: Tennis Elbow; Lateral Epicondylitis

Summary: the investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

lateral epicondylitis or tennis elbow is a tendinopathy of the common extensor origin of the lateral elbow, and is estimated to have an annual incidence of 1-3%. it is characterized by tenderness over the lateral epicondyle of the humerus, normal range of motion, and pain on resisted extension of the wrist or fingers. symptoms can persist for between 6 months and 2 years but usually resolve within 12 months. although tennis elbow is often self-limited, around 20% of cases are refractory to conservative care. tennis elbow is now thought to be non-inflammatory, and the pathologies are characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration, and neovascularization. treatment of tennis elbow includes relative rest, physical therapy (therapeutic exercise, massage, therapeutic ultrasound, lower power laser, etc.), analgesics, non-steroidal anti-inflammatory drugs, glyceryl trinitrate patches, injection therapy (corticosteroid, hyaluronan gel, botulinum toxin, and autologous platelet-rich plasma), shock wave therapy, and even surgery. previous studies showed corticosteroid injection is effective in the short term, but is harmful in the long-term, and is more likely to have a recurrence. in consideration of a degenerative lesion in tennis elbow, corticosteroid injection may be not an ideal agent. although plate-rich plasma injection showed promising results, the high cost limited its widespread clinical use. since local lidocain injection is commonly used in the management of myofascial pain syndrome, it might be effective in the treatment of tendinopathy like tennis elbow. the purpose of this study is to compare the effect of corticosteroid injection and lidocain injection in the treatment of tennis elbow. the investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

Eligibility criteria:
inclusion criteria: * between 20 and 75 years of age, with lateral elbow pain ≥4 in pain vas for at least 1 month * reproducibility of pain by 2 or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow; resisted wrist extension (dorsiflexion) and pronation with the elbow in extension * pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension. exclusion criteria: * not fulfill inclusion criteria

Keywords: lateral epicondylitis tennis elbow lidocaine corticosteroid
acromegaly treatment quality of life study

Conditions: Acromegaly

Summary: the investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. at the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.


Eligibility criteria:
inclusion criteria: * age 18-90 * active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy exclusion criteria: * untreated thyroid or adrenal insufficiency. subjects on replacement therapy must be stable for at least 3 months prior to entry into the study * initiation or discontinuation of testosterone or estrogen within 3 months of entry * pregnant and nursing women
adrenal insufficiency in cirrhotics with ascites. effects of hydrocortisone on renal and haemodynamic function

Conditions: Cirrhosis With Ascites

Summary: relative adrenal insufficiency (rai) is an well known condition in patients with septic shock. liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines. hydrocortisone has been shown to have a beneficial effect on clinical outcome. the aim of this study is to evaluate the incidence of rai in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.


Eligibility criteria:
inclusion criteria: * cirrhosis with ascites, with or without hepatorenal syndrome exclusion criteria: * age \ 75 years * shock or bacterial infection present at the inclusion or during the previous week * bleeding present at the inclusion or during the previous week * multifocal hcc * organic renal failure * hearth or pulmonary failure

Keywords: cirrhosis ascites adrenal insufficiency hepatorenal syndrome portal hypertension
study of the safety and efficacy of fixed-dose brexpiprazole (opc-34712) as adjunctive therapy in the treatment of adults with major depressive disorder with and without anxious distress

Conditions: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders

Summary: the purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of mdd with and without anxious distress

the introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for mdd, particularly for treatment-resistant mdd. several atypical antipsychotics have been shown to enhance the response to adt. this is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label adt in depressed subjects with and without anxious distress.

Eligibility criteria:
inclusion criteria: * male and female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress * current depressive episode must be at least 8 weeks in duration exclusion criteria: * subjects with a history of neuroleptic malignant syndrome or serotonin syndrome * subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode * subjects with a current axis i diagnosis of: delirium, dementia, amnestic or other cognitive disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar i or ii disorder

Keywords: opc-34712 brexpiprazole major depressive disorder adjunctive treatment anxious distress
efficacy and the safety of regorafenib in patients aged more than 70 years with a metastatic colorectal adenocarcinoma .

Conditions: Colorectal Adenocarcinoma

Summary: multicenter prospective phase ii study evaluating regorafenib in older patients with metastatic colorectal cancer


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer with histological proof * measurable disease according recist 1.1 * age ≥ 70 years * ecog ≤ 1 * biological values haemoglobin ≥ 9 g/dl, pnn ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5n, asat, alat et pal ≤ 2,5n (≤ 5n if hepatic metastases), lipase ≤1,5n, tp≥ 70%, creatinine clairance ≥ 30 ml/min * patient without response to 5fu chemotherapy or anti-vegf treatment or anti egfr treatment (if ras wild-type), in progression during this treatment or treatment stopped because of toxicities * geriatric questionnaires answered * life-expectancy ≥ 3 months * informed consent signed exclusion criteria: * not able to swallow tablets (crushed tablets are not allowed) * previous treatment with regorafenib or other multikinase treatment * other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated * radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion * toxicity \> grade 1 not resolved with previous treatment * major surgery in the 28 days before the inclusion * non cicatrized injury, ulcer or bone fracture * congestive cardiac insufficiency classe \>2 (nyha) * unstable angor in the last 3 months * myocardial infraction in the 6 months before inclusion * hta not controlled * pheochromocytome * arterial or venous thromboembolism in the past 6 months * infection of grade \> 2 * vih infection * b or c hepatitis necessiting a specific treatment * cirrhosis * suspicion of brain metastasis or brain metastasis * haemorraghe ofgrade \>3 in the last weeks * symptomatic pulmonary fibrosis * proteinuria \> grade 3 * malabsorption * allergy know to the treatment or to one similar treatment or to one treatment component * systemic anti-cancer drug during the study or the the last 4 weeks * concomitant treatment with cyp3a4 inhibitor or inductor or with ugt1a9 inhibitor * social, psychological or medical condition which can interfere with the study participation
velcade in malt lymphoma patients

Conditions: MALT Lymphoma

Summary: bortezomib for treatment of disseminated malt lymphoma or at relapse following hp -eradication,or chemotherapy or radiation.

the objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated malt lymphoma or at relapse following hp-eradication, or chemotherapy or radiation. it is a phase ii prospective single arm study with a target sample of 16 patients. 1.5mg/m2 bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed malt lymphoma with measurable disease (stage i-iv) * with first or greater relapse after hp-eradication, radiation or chemotherapy , * age \> 18 years * must be able to tolerate therapy and have adequate cardiac, renal and hepatic function * ecog status of \<_ 2 * must be capable of understanding the purpose of the study and given written informed consent

Keywords: malt lymphoma, bortezomib